- Role
- Country
- Date of registration
- Address
CN-MF-000024842Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Dymind Biotechnology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Mar 25, 2026
B-06976117450974Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06976117450974
1 warning recorded — scroll inside the panel to see all entries.
CW011Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06976117450974Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06976117450974NX-0001-05UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103020102ACTIVATED PARTIAL THROMBOPLASTIN TIMECertificate health across this manufacturer's portfolio.
HX 2183501-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
697049309W01030000023A2On the marketHematology Analyzer Lyse697049309W01030000023A2On the market25-Hydroxyvitamin D Kit (Fluorescence Immunochromatography)B-06941377306453On the marketActivated Partial Thromboplastin Time Assay Kit (Coagulation Method )B-06976117450936On the marketActivated Partial Thromboplastin Time Assay Kit (Coagulation Method )B-06976117450950On the marketActivated Partial Thromboplastin Time Assay Kit (Coagulation Method )B-06976117450967On the market